MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION; IV START KIT

Model Number IV8595

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Filing for initial report, investigation is ongoing.

Event Description

Leaking occurred at the connection of the iv catheter and the extension set.

• Brand Name: CENTURION
• Type of Device: IV START KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston MI 48895
• Manufacturer (Section G): TRI-STATE DE MEXICO, S. DE R.L. DE C.V.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: matthew price ; 100 centurion way; williamston, MI 48895 ; 5175465400
• MDR Report Key: 7173077
• MDR Text Key: 96846729
• Report Number: 3004519921-2018-00001
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: IV8595
• Device Lot Number: 2017082390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention